BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814305·GENUMEDI PT SILVER R VII

    Magellan Robotic System, Magellan Robotic Catheter 10Fr

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550223·GENUMEDI PT KNEE SUP SILVER R EW VII

    PERIARTICULAR LOCKING PLATES, 2358 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ORATECT ORAL FLUID DRUG SCREEN DEVICES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·November 13, 2020

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·June 28, 2011

    VERITY ADX SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code LWP·January 13, 2014

    EQUINOXE

    FDA Adverse Event
    Other ·EXATECH INC.·Product code HSD·May 28, 2013

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·February 5, 2014

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·January 6, 2014